The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Despite the setbacks in the global markets since the beginning of 2016, the valuations of biotechnology companies remain attractive in comparison to the S&P and are based on strong fundamentals, says Carl Harald Janson, investment manager at SV Life Sciences Managers. 19 April 2016
Concerned at being sidelined from the USA-led Trans-Pacific Partnership (TPP) trade deal, India is preparing to reach a deal this year amidst preparations to deal with the adverse impact. 18 April 2016
Australian regulator the Therapeutic Goods Administration (TGA) has approved a variation to expand the current therapeutic indication for Volibris (ambrisentan) to include its use in combination treatment with tadalafil for patients with pulmonary arterial hypertension (PAH) in Australia. 18 April 2016
Activist fund Starboard Value targeted Depomed, a small drug maker with an approximate $1 billion market capitalization late last week, wrote Bret Jensen, a regular contributor to the Seeking Alpha blog. 17 April 2016
Boehringer Ingelheim said on Friday that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for its lung cancer therapy Gilotrif (afatinib). 16 April 2016
The National Institute for Health and Care Excellence (NICE) on Friday recommended Translarna (ataluren), from US pharma company PTC Therapeutics for treating children aged five and over with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation. 16 April 2016
In April, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started a new safety review and extended the scope of an ongoing review procedure. 15 April 2016
The Strategic Advisory Group of Experts on Immunization (SAGE) has issued its recommendations to the World Health Organization on the use of Dengvaxia dengue vaccine, from Sanofi Pasteur. 15 April 2016
New European Union rules to help companies win legal redress against theft or misuse of their trade secrets were voted by Parliament today (April 14). 14 April 2016
The USA’s Physicians Payment Sunshine Act, proposed in 2010 and started in 2013, was created to make the financial relationship between health care providers and the pharmaceutical industry more transparent. 14 April 2016
The US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) from pharma major Bristol-Myers Squibb, which seeks to expand the use of Opdivo (nivolumab) to patients with classical Hodgkin lymphoma (cHL) after prior therapies. 14 April 2016
US drug giant Merck & Co is a step closer to making Keytruda (pembrolizumab), its already marketed cancer drug, as a treatment for head and neck cancer, available to patients. 14 April 2016
The Russian government has designed a new package of measures aimed at providing support to domestic drugmakers as well as global majors, operating their plants within the country. 14 April 2016
The European Medicines Agency and the European network for Health Technology Assessment (EUnetHTA) today published a report on their joint work plan covering the period between November 2012 and December 2015. 14 April 2016
USA’s Merck & Co and Japanese drugmaker Taiho, a subsidiary of Otsuka, have announced a co-promotion agreement in Japan for the cancer treatment pembrolizumab. 13 April 2016
US Republic Presidential contender Donald Trump recently released a healthcare reform plan, which the presigious US think-tank Pacific Research Institute (PRI) has assessed. 13 April 2016
The companion diagnostic for chronic lymphocytic leukemia (CLL) treatment Venclexta (venetoclax) has received approval a day after the drug itself was given the green light by the US Food and Drug Administration (FDA). 13 April 2016